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NCT02727660 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,876
- Enrollment target
NCT02727660: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT02727660 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 1,876 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02727660, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,876 participants
- Enrollment target
Study Summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
Primary Outcome
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Interventions
- DRUG BFF MDI (PT009) 320/9.6 μg
- DRUG BFF MDI (PT009) 160/9.6 μg
- DRUG FF MDI (PT005) 9.6 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,876 participants |
| Start Date | 2016-04-29 |
| Est. Completion | 2018-04-04 |
| Phase | Phase 3 |
What the finished NCT02727660 record still lists
NCT02727660 is an interventional study that assigns participants to a tested intervention. Its 1,876 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 3 interventions - of which BFF MDI (PT009) 320/9.6 μg is the first listed.
NCT02727660 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02727660 about?
NCT02727660 is a clinical study titled "A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)". This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
What is the current status of trial NCT02727660?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,876 participants. The study started on 2016-04-29. Estimated completion is 2018-04-04.
What interventions are being tested in trial NCT02727660?
The interventions under investigation include: BFF MDI (PT009) 320/9.6 μg (DRUG), BFF MDI (PT009) 160/9.6 μg (DRUG), FF MDI (PT005) 9.6 μg (DRUG).
Who is sponsoring clinical trial NCT02727660?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02727660's enrollment target sits among peer trials
1,876 113th of 2000 higher than 1,888 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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